Tiziana Life Sciences Ltd (NASDAQ:TLSA) has announced the discovery of new immune biomarkers in patients with non-active secondary progressive multiple sclerosis (na-SPMS) treated with its novel therapy nasal foralumab.
The company’s study detected changes in gene expression starting three months after patients received intranasal foralumab in the ongoing ISPPEA (Expanded Access Program).
Key immune biomarkers were identified, including modulation of FoxP3 T regulatory cells, central memory T cells, and monocytes. These biomarkers are linked to immune processes like antigen presentation and interferon responses.
Using single-cell RNA sequencing, researchers observed these gene expression changes after three and six months of treatment, correlating with reduced brain inflammation in patients, as seen through advanced microglial PET scans.
“The observed clinical stabilization and microglial PET findings are supported by these new biomarker discoveries, providing compelling evidence of nasal foralumab's biological effects,” Tiziana scientific advisory board chairman Dr Howard Weiner said.
“The identification of these biomarkers not only strengthens our understanding of the treatment’s mechanism but also establishes a framework for monitoring its efficacy in future trials and may establish a framework for monitoring a patient’s response to foralumab treatment.”
Ivor Elrifi, Tiziana CEO, said the findings further confirmed the potential of foralumab.
“Foralumab, the first fully human anti-CD3 monoclonal antibody, is in a Phase 2 trial as a groundbreaking immunomodulatory therapy with applications in autoimmune and neurodegenerative diseases,” Elrifi said. “These findings further confirm its potential and set the stage for broader clinical exploration.”
Investors welcomed the announcement, sending Tiziana as much as 19% higher afterhours on Wednesday.